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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01124331
Registration number
NCT01124331
Ethics application status
Date submitted
13/05/2010
Date registered
17/05/2010
Date last updated
13/03/2019
Titles & IDs
Public title
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
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Scientific title
Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
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Secondary ID [1]
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NeOProM
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Universal Trial Number (UTN)
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Trial acronym
NeOProM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infant, Premature, Diseases
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Bronchopulmonary Dysplasia
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Retinopathy of Prematurity
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Infant, Newborn, Diseases
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Infant, Very Low Birth Weight
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
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Complications of newborn
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Eye
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Diseases / disorders of the eye
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Higher oxygen saturation target range (91%-95%)
Treatment: Surgery - Lower oxygen saturation (85%-89%)
Experimental: High Oxygen saturation - Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.
Active comparator: Lower oxygen saturation - Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.
Treatment: Surgery: Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
Treatment: Surgery: Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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composite outcome of death or major disability by 18-24 months corrected age
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Assessment method [1]
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Major disability is defined as any of the following:
* Bayley-III Developmental Assessment cognitive score \<85 and/or language score \<85
* Severe visual loss
* Cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher at 18-24 months postmenstrual age
* Deafness requiring hearing aids
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Timepoint [1]
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by 18-24 months corrected age (gestational age plus chronological age)
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Secondary outcome [1]
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Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection
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Assessment method [1]
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Timepoint [1]
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at 18-24 months corrected age
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Secondary outcome [2]
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measures of respiratory support
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Assessment method [2]
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• Measures of respiratory support, including the following separate outcomes a. supplemental oxygen requirement at 36 weeks postmenstrual age, b. postmenstrual age ceased endotracheal intubation, c. postmenstrual age ceased continuous positive airway pressure (CPAP), d. postmenstrual age ceased supplemental oxygen, e. postmenstrual age ceased home oxygen (if received).
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Timepoint [2]
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36 weeks postmenstrual age
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Secondary outcome [3]
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Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment
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Assessment method [3]
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Timepoint [3]
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at 18-24 months corrected age
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Secondary outcome [4]
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Patent ductus arteriosus receiving surgical treatment
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Assessment method [4]
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Timepoint [4]
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at 18-24 months corrected age
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Secondary outcome [5]
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Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
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Assessment method [5]
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Timepoint [5]
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18-24 months corrected age
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Secondary outcome [6]
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Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
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Assessment method [6]
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Timepoint [6]
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at 36 weeks' postmenstrual age and discharge home
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Secondary outcome [7]
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Re-admissions to hospital
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Assessment method [7]
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Timepoint [7]
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up to 18-24 months postmenstrual age
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Secondary outcome [8]
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Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age
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Assessment method [8]
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Timepoint [8]
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at 18-24 months corrected age
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Secondary outcome [9]
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Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial)
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Assessment method [9]
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Timepoint [9]
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at 18-24 months corrected age
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Secondary outcome [10]
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deafness requiring hearing aids
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Assessment method [10]
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Timepoint [10]
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at 18-24 months corrected age
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Secondary outcome [11]
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Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
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Assessment method [11]
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Timepoint [11]
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2 years corrected age
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Secondary outcome [12]
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death
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Assessment method [12]
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Timepoint [12]
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at 18-24 months corrected age
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Eligibility
Key inclusion criteria
* Infants < 28wks gestation
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Minimum age
No limit
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Maximum age
24
Hours
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Infants > 28wks gestation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2014
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Sample size
Target
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Accrual to date
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Final
4965
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Royal Prince Alfred Hospital Women and Babies - Camperdown
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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John Hunter Hospital - New Lambton
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Recruitment hospital [5]
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Royal North Shore Hospital, NSW - St Leonards
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Recruitment hospital [6]
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Westmead Hospital, - Westmead
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Recruitment hospital [7]
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Royal Brisbane Women's Hospital - Brisbane
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Recruitment hospital [8]
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Royal Women's Hospital - Melbourne
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Recruitment hospital [9]
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Monash Medical Centre - Melbourne
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Recruitment postcode(s) [1]
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- Canberra
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2310 - New Lambton
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Recruitment postcode(s) [5]
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- St Leonards
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment postcode(s) [7]
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4006 - Brisbane
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Recruitment postcode(s) [8]
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3052 - Melbourne
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Recruitment postcode(s) [9]
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3800 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Otago
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Oxford
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Pennsylvania
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of California, San Diego
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?
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Trial website
https://clinicaltrials.gov/study/NCT01124331
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Trial related presentations / publications
Askie LM, Brocklehurst P, Darlow BA, Finer N, Schmidt B, Tarnow-Mordi W; NeOProM Collaborative Group. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatr. 2011 Jan 17;11:6. doi: 10.1186/1471-2431-11-6. Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, Davis PG, Carlo WA, Brocklehurst P, Davies LC, Das A, Rich W, Gantz MG, Roberts RS, Whyte RK, Costantini L, Poets C, Asztalos E, Battin M, Halliday HL, Marlow N, Tin W, King A, Juszczak E, Morley CJ, Doyle LW, Gebski V, Hunter KE, Simes RJ; Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA. 2018 Jun 5;319(21):2190-2201. doi: 10.1001/jama.2018.5725. Erratum In: JAMA. 2018 Jul 17;320(3):308. doi: 10.1001/jama.2018.9635.
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Public notes
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Contacts
Principal investigator
Name
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Lisa Askie
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Address
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National Health and Medical Research Council, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT01124331
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